Advanced Solid Tumours Clinical Trial
Official title:
A Dose Finding Pharmacokinetic Study of the Tumour-targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients With Advanced Solid Tumours
This is a Phase I/II study for patients with solid tumors and renal cell carcinoma (RCC; for the Phase II part). L19-IL2 is a tumor targeted immunocytokine constituted of a single chain Fragment variable (scFv) format directed against the ED-B domain of fibronectin, one of the most important markers for neoangiogenesis, and the human cytokine interleukin-2 (IL2).
This is an open-label, non-randomised, multicentre, Phase I/II study to assess safety,
pharmacokinetics (PK), and early signs of activity of L19-IL2 monotherapy.
In the first part of the study, there will be 5 dose escalation steps in sequential cohorts
of patients with advanced solid tumours. In the second part of the study, patients with
advanced RCC will be given a fixed dose of L19IL2 at the RD.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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